XBiotech Inc. is a biopharmaceutical firm specializing in the discovery, development, and commercialization of True Human monoclonal antibodies. Their primary focus involves building a robust pipeline of product candidates aimed at combating both inflammatory and infectious diseases. Furthermore, the company is advancing interleukin-1 alpha-based therapies, which are designed to address a broad spectrum of medical conditions such as cancer, stroke, heart attack, and arthritis. Interleukin-1 alpha itself plays a crucial role in biological processes like tissue breakdown, angiogenesis, blood clot formation, malaise, muscle wasting, and inflammation. Additionally, XBiotech is developing a True Human COVID-19 therapy specifically targeting mutant strains of the virus. Established in 2005, XBiotech Inc. maintains its headquarters in Austin, Texas.
XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug for the Treatment of Active Axial Spondyloarthritis
XBiotech announced that the FDA completed its 30-day review of the IND application for the V-SPINE study without placing a clinical hold, clearing the path for U.S. patient enrollment.
The Phase II, double-blind, placebo-controlled trial will evaluate 400 mg of vilamakitug administered via 16 weekly subcutaneous injections in 150 adult participants with active axial spondyloarthritis.
The primary endpoint is the proportion of participants achieving an ASAS40 response at Week 16, with a 12-week open-label extension planned for all participants.
This milestone marks the resumption of XBiotech’s rheumatology program, leveraging its True Human™ antibody platform to target IL-1α, an upstream inflammatory mediator.